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FDA 510(k)

BELMONT QUOLIS 5000 SERIES DENTAL UNIT

K-Number: K072273 · 2007-12-20

ApplicantTakara Belmont USA, Inc.
Decision Date2007-12-20
Product CodeNRD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BELMONT QUOLIS 5000 SERIES DENTAL UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Takara Belmont USA, Inc.. It received FDA 510(k) clearance on 2007-12-20 under 510(k) number K072273. The device is classified under product code NRD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELMONT QUOLIS 5000 SERIES DENTAL UNIT?

BELMONT QUOLIS 5000 SERIES DENTAL UNIT is a medical device that received FDA 510(k) clearance on 2007-12-20. The listed applicant is Takara Belmont USA, Inc.. The 510(k) number is K072273.

When did BELMONT QUOLIS 5000 SERIES DENTAL UNIT receive FDA 510(k) clearance?

BELMONT QUOLIS 5000 SERIES DENTAL UNIT received FDA 510(k) clearance on 2007-12-20, under 510(k) number K072273.

Who is the listed applicant for BELMONT QUOLIS 5000 SERIES DENTAL UNIT?

The FDA 510(k) record lists Takara Belmont USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BELMONT QUOLIS 5000 SERIES DENTAL UNIT?

The FDA product code for BELMONT QUOLIS 5000 SERIES DENTAL UNIT is NRD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Takara Belmont USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K102456INTRAORAL BELSENSOR GOLDK062529BELMAX CM MODEL X168K041834ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CMK042260PHOT-X II, MODEL 303K040748ANA-BEL, MODEL 087D AND ANA-BEL CM, MODEL 187-CM

Related Devices (Code: NRD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K042266ACCLAIMAir Techniques, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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